Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

MM-121 + Exemestane

MM-121 and Exemestane: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day

Placebo + Exemestane

Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day

To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Exemestane in Formalin Fixed (FFPE) Tumor Samples [ Time Frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
If no overall study publication has occurred by the Sponsor within 12 months of the completion of this Study, the Investigator shall have the right to publish or present independently the results of this Study subject to the review procedure set forth herein. The Investigator will provide the Sponsor with a copy of any such presentation or publication derived from the Study for review, and the Sponsor may delay publication for up to 90 days to preserve patent activities and proprietary rights.